Properties of the weighted log‐rank test in the design of confirmatory studies with delayed effects

Proportional hazards are a common assumption when designing confirmatory clinical trials in oncology. This assumption not only affects the analysis part but also the sample size calculation. The presence of delayed effects causes a change in the hazard ratio while the trial is ongoing since at the beginning we do not observe any difference between treatment arms, and after some unknown time point, the differences between treatment arms will start to appear. Hence, the proportional hazards assumption no longer holds, and both sample size calculation and analysis methods to be used should be reconsidered. The weighted log‐rank test allows a weighting for early, middle, and late differences through the Fleming and Harrington class of weights and is proven to be more efficient when the proportional hazards assumption does not hold. The Fleming and Harrington class of weights, along with the estimated delay, can be incorporated into the sample size calculation in order to maintain the desired power once the treatment arm differences start to appear. In this article, we explore the impact of delayed effects in group sequential and adaptive group sequential designs and make an empirical evaluation in terms of power and type‐I error rate of the of the weighted log‐rank test in a simulated scenario with fixed values of the Fleming and Harrington class of weights. We also give some practical recommendations regarding which methodology should be used in the presence of delayed effects depending on certain characteristics of the trial.     

Modifications of sequential designs in bioequivalence trials

Bioequivalence (BE) studies are designed to show that two formulations of one drug are equivalent and they play an important role in drug development. When in a design stage, it is possible that there is a high degree of uncertainty on variability of the formulations and the actual performance of the test versus reference formulation. Therefore, an interim look may be desirable to stop the study if there is no chance of claiming BE at the end (futility), or claim BE if evidence is sufficient (efficacy), or adjust the sample size. Sequential design approaches specially for BE studies have been proposed previously in publications. We applied modification to the existing methods focusing on simplified multiplicity adjustment and futility stopping. We name our method modified sequential design for BE studies (MSDBE). Simulation results demonstrate comparable performance between MSDBE and the original published methods while MSDBE offers more transparency and better applicability. The R package MSDBE is available at https://sites.google.com/site/modsdbe/ . Copyright © 2015 John Wiley & Sons, Ltd.     

Analyzing multiple vector autoregressions through matrix-variate normal distribution with two covariance matrices

Abstract

This article proposes a new approach to analyze multiple vector autoregressive (VAR) models that render us a newly constructed matrix autoregressive (MtAR) model based on a matrix-variate normal distribution with two covariance matrices. The MtAR is a generalization of VAR models where the two covariance matrices allow the extension of MtAR to a structural MtAR analysis. The proposed MtAR can also incorporate different lag orders across VAR systems that provide more flexibility to the model. The estimation results from a simulation study and an empirical study on macroeconomic application show favorable performance of our proposed models and method.     

Product partition latent variable model for multiple change-point detection in multivariate data

The product partition model (PPM) is a well-established efficient statistical method for detecting multiple change points in time-evolving univariate data. In this article, we refine the PPM for the purpose of detecting multiple change points in correlated multivariate time-evolving data. Our model detects distributional changes in both the mean and covariance structures of multivariate Gaussian data by exploiting a smaller dimensional representation of correlated multiple time series. The utility of the proposed method is demonstrated through experiments on simulated and real datasets.     

State work and the testing concours of citizenship

Anyone trying to be a citizen has to pass through a set of practices trying to be a state. This paper investigates some of the ways testing practices calibrate citizens, and in doing so, perform “the state.” The paper focuses on three forms of citizenship testing, which it considers exemplary forms of “state work,” and which all, in various ways, concern “migration.” First, the constitution of a “border crossing,” which requires an identity test configured by deceptibility. Second, the Dutch asylum process, in which “being gay” can, in certain cases, be reason for being granted asylum, but where “being gay” is also the outcome of an examination organized by suspicion. And third, the Dutch measurement of immigrants’ “integration,” which is comprised of a testing process in which such factishes as “being a member of society” and “being modern” surface. Citizenship is analyzed in this paper as accrued and (re)configured along a migration trajectory that takes shape as a testing concours, meaning that subjects become citizens along a trajectory of testing practices. In contributing both to work on states and citizenship, and to work on testing, this paper thus puts forward the concept of citizenship testing as state work, where “state work is the term for that kind of labor that most knows itself as comparison, equivalency, and exchange in the social realm” (Harney, 2002, pp. 10–11). Throughout the testing practices discussed here, comparison, equivalency, and exchange figure prominently as the practical achievements of crafting states and citizens.     

Subjective utility with upper and lower probabilities on finite states

This article is concerned with thresholds of discrimination of preference judgments under uncertainty. We establish an axiomatic characterization for a threshold representation, where thresholds are represented by inexact measurement of subjective probabilities, i.e., upper and lower probabilities. Since upper and lower probabilities need not be additive, the representational form adopts the Choquet integration.     

虚拟空间交织的取向原则

虚拟空间交织是人们常用的思维与认知方式之一。本文通过对交织及其原则的介绍,描述了虚拟空间交织的运作,指出虚拟空间交织构建中主观取向的原则应为最佳关联。     

供应链与海尔的战略调整

供应链是现代工商业的一种新的业态形式 ,它通过有效的客户和市场管理、对客户需求的准确预测和迅速反应以及最大程度地降低从原材料到生产、再到销售整个过程的库存和运转费用 ,为终端顾客提供最大的让渡价值 ,提高供应链成员整体的竞争力。海尔集团以超前性的战略眼光对公司的组织管理结构和经营方式进行了战略性的调整 ,为推行供应链管理和经营创造了条件。